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  3. Recall Enforcement Event ID: 81887

Recall Enforment Report D-0367-2019

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Aurobindo Pharma USA Inc., originally initiated on 12-31-2018 for the product Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-551-90. The product was recalled due to cgmp deviations: fda lab confirmed presence an impurity, n-nitrosodimethylamine (ndea) contained in the api used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.. The product was distributed in Product Was Distributed To 25 Distributors And Retail Chains Who May Have Further Distributed The Product Throughout The United States. and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0367-201912-31-201801-23-2019Class II111,239 bottlesValsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-551-90.CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.Ongoing
D-0370-201912-31-201801-23-2019Class II20,604 bottlesValsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-573-90.CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.Ongoing
D-0364-201912-31-201801-23-2019Class II55,788 bottlesAmlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-740-30.CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.Ongoing
D-0366-201912-31-201801-23-2019Class II92,616 bottlesValsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-548-90.CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.Ongoing
D-0368-201912-31-201801-23-2019Class II32,160 bottlesValsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-547-90.CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.Ongoing
D-0362-201912-31-201801-23-2019Class II60,417 bottlesAmlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-739-30.CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.Ongoing
D-0361-201912-31-201801-23-2019Class II18,408 bottlesAmlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.Ongoing
D-0369-201912-31-201801-23-2019Class II53,064 bottlesValsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-549-90.CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.Ongoing
D-0363-201912-31-201801-23-2019Class II27,688 bottlesAmlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-738-30.CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.Ongoing
D-0365-201912-31-201801-23-2019Class II23,016 bottlesValsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-550-90.CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
65862-547 Valsartan And HydrochlorothiazideTablet, Film CoatedAurobindo Pharma LimitedDrug For Further Processing
65862-547Valsartan And Hydrochlorothiazide Valsartan And HydrochlorothiazideTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-548 Valsartan And HydrochlorothiazideTablet, Film CoatedAurobindo Pharma LimitedDrug For Further Processing
65862-548Valsartan And Hydrochlorothiazide Valsartan And HydrochlorothiazideTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-549 Valsartan And HydrochlorothiazideTablet, Film CoatedAurobindo Pharma LimitedDrug For Further Processing
65862-549Valsartan And Hydrochlorothiazide Valsartan And HydrochlorothiazideTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-550 Valsartan And HydrochlorothiazideTablet, Film CoatedAurobindo Pharma LimitedDrug For Further Processing
65862-550Valsartan And Hydrochlorothiazide Valsartan And HydrochlorothiazideTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-551 Valsartan And HydrochlorothiazideTablet, Film CoatedAurobindo Pharma LimitedDrug For Further Processing
65862-551Valsartan And Hydrochlorothiazide Valsartan And HydrochlorothiazideTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-570 ValsartanTablet, Film CoatedAurobindo Pharma LimitedDrug For Further Processing
65862-570Valsartan ValsartanTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-571 ValsartanTablet, Film CoatedAurobindo Pharma LimitedDrug For Further Processing
65862-571Valsartan ValsartanTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-572 ValsartanTablet, Film CoatedAurobindo Pharma LimitedDrug For Further Processing
65862-572Valsartan ValsartanTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-573 ValsartanTablet, Film CoatedAurobindo Pharma LimitedDrug For Further Processing
65862-573Valsartan ValsartanTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-737Amlodipine And Valsartan Amlodipine And ValsartanTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-738Amlodipine And Valsartan Amlodipine And ValsartanTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-739Amlodipine And Valsartan Amlodipine And ValsartanTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-740Amlodipine And Valsartan Amlodipine And ValsartanTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug